FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Sweden)
FDA refused a dermal collagen implant shipment from Sweden.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated September 1, 2026, in the Aesthetic Injectables category.
An import refusal marks a shipment the FDA stopped at the U.S. border as violative — the gray-market corridor a med spa must never source injectables from. Foreign, unapproved, or misbranded product refused at import is exactly what surfaces when a practice buys outside verified US-licensed 503A/503B or FDA-registered channels.
- Type
- FDA Import Refusal
- Jurisdiction
- Federal
- Category
- Aesthetic Injectables
- Recorded
- September 1, 2026
What this means for your practice — the step to take, the deadline to calendar or the supplier detail to check, where the change calls for one — is in the member "what to do" below. This page is the free record of what changed and why it matters.
What to do
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The FDA record
- Firm
- Q-Med AB
- Origin
- Uppsala, Sweden
- Product
- Implant, Dermal, Collagen For Aesthetic Use
- FDA classification
- General and Plastic Surgery Medical Devices
- Refused
- Sep 1, 2026
- FDA district
- Division of Northeast Imports
- Firm FEI
- 3003347293
- FDA shipment ID
- 1FX-7843473-5/10002/1
Why FDA refused it
Misbranding801(a)(3); 502(o) Misbranding
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FDA charge codes on this record: 508 (Misbranding). Definitions via the FDA Refusal Charges Reference.
Verify at FDA
FDA doesn’t publish a page per refusal. Open the FDA Import Refusals database and search by shipment ID 1FX-7843473-5/10002/1 (or firm FEI 3003347293), refused Sep 1, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Q-Med AB · Uppsala · plastic-surgery device · refused as misbranding
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